Skin treatment with salicylic acid esters

ABSTRACT

A method and composition is provided for treating skin conditions including those arising from dermatologic disorders, chronoaging and environmental abuse. Non-ring esterified C11-C30 alkyl or alkenyl esters of salicylic acid are used as the active component in combination with a pharmaceutically acceptable carrier. Most preferred is tridecyl salicylate.

This is a Continuation-In-Part patent application of Ser. No.08/670,390, Filed Jun. 25, 1996.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention concerns methods of treating skin withcompositions containing certain esters of salicylic acid.

2. The Related Art

Skin is subject to deterioration through dermatologic disorders ornormal aging (chronoaging) as well as extrinsic factors (environmental).Dermatologic disorders include such conditions as acne, dry skin,dandruff, keratosis, pruritus, inflammatory dermatoses, eczema,psoriasis and tenia pedis (athlete's foot).

Chronoaging results in the thinning and general degradation of skin. Asskin naturally ages, there is reduction in the cells and blood vesselsthat supply the skin. There is also a flattening of the dermal-epidermaljunction which results in weaker mechanical resistance. Olderindividuals increasingly develop facial fine lines, wrinkles,leatheriness, yellowing, sagging, mottling (hyperpigmentation), agespots and the general signs of aging.

Extrinsic factors are primarily those caused by exposure to sun. Changesare most prominent in light skinned individuals who burn easily and tanpoorly. The results of photodamage may be identical to those of agingexcept appearing at an accelerated rate. Wrinkling, yellowing,leatheriness, mottling and hyperpigmentation are all associated with sundamage. Most disturbing to many individuals is the wrinkling effect. Itis a prime reminder of the disappearance of youth. As a result, therehave been many reports of cosmetic treatments aimed at the eliminationof wrinkles.

PCT applications WO 93/10755 and WO 93/10756 report salicylic acid as aneffective anti-wrinkling agent. U.S. Pat. No. 5,262,407 reports use ofring acylated salicylic acid as a treatment against skin aging.Salicylic acid has also been described for the treatment of acne in U.S.Pat. No. 4,891,227 and U.S. Pat. No. 4,891,228. Moreover, salicylic acidhas been used for the removal of warts, corns and calluses; for thetreatment of psoriasis, seborrheic dermatitis and dandruff; and for thetopical treatment of ringworm infection. A listing of commerciallyavailable products containing salicylic acid will be found in thePhysician's Desk Reference, 45th Edition, 1991, page 323.

Ring alkylated salicylic acid has been reported in Japanese Patent4036238 (Takasago Perfumery KK) for treatment of acne vulgaris.

Significant irritation is often associated with the use of salicylicacid. Another problem is that salicylic acid is not always readilyformulatable into oily compositions. Derivatives of salicylic acid mostoften leave the acidic function free. Irritation caused by acidity istherefore not prevented by such derivatives.

Accordingly it is an object of the present invention to provide atreatment for a variety of dermatologic disorders such as acne, dryskin, dandruff, keratosis, pruritus, inflammatory dermatosis, eczema,psoriasis and tinea pedis.

Another object of the present invention is to provide a treatment forchronoaging conditions including wrinkling and fine lines, leatheriness,yellowing, sagging, mottling (hyperpigmentation), age spots and thegeneral signs of aging.

Still a further object of the present invention is to provide atreatment for acne and pimples.

Still another object of the present invention is to provide a treatmentagainst environmental abuse to skin including wrinkling and fine lines,yellowing, leatheriness, mottling and hyperpigmentation.

Yet another object of the present invention is to provide a treatment toimprove the condition of skin with a composition and active that doesnot impart irritation.

These and other objects of the present invention will become morereadily apparent from the following summary and detailed discussion.

SUMMARY OF THE INVENTION

A method is provided for treating skin conditions selected from thegroup consisting of dermatologic skin disorders, chronoaging,environmental abuse and combinations thereof, by applying to the skin acomposition including as an active a salicylate ester having thestructure (I): ##STR1## wherein R is a C₁₁ -C₃₀ alkyl or alkenylradical.

DETAILED DESCRIPTION OF THE INVENTION

Now it has been discovered that deterioration of skin throughdermatologic disorders, chronoaging and environmental abuse (e.g. sunand wind) can be reduced, inhibited and even reversed throughapplication of a cosmetic composition including as active a non-ringester derivative of salicylic acid having formula (I): ##STR2## whereinR is a C₁₁ -C₃₀ alkyl or alkenyl radical. Most preferred are the C₁₂-C₂₀ alkyl or alkenyl, optimally the C₁₃ alkyl or alkenyl esters ofsalicylic acid.

"Safe and effective amounts" of the C₁₁ -C₃₀ esters of salicylic acidare to be used within cosmetic compositions of the present invention.The term "safe and effective amounts" are defined as any amountsufficient to significantly induce a positive modification in thecondition to be treated, but low enough to avoid serious side effects(at a reasonable benefit/risk ratio), within the scope of sound medicaljudgement. The safe and effective amount of the salicylate esters willvary with the particular condition being treated, the age and physicalcondition of the patient being treated, the severity of the condition,the duration of the treatment, the nature of concurrent therapy, thespecific ester employed, the particular pharmaceutically-acceptablecarrier utilized, and like factors in the knowledge and expertise of theattending physician. Generally these amounts may range from 0.01 to 20%,preferably from 0.1 to 10%, more preferably from 1 to 8%, optimally from2 to 6% by weight.

Besides the active salicylate ester, compositions of the presentinvention will utilize a pharmaceutically acceptable carrier. Thecarrier may either be aqueous, anhydrous or an emulsion. Preferably thecompositions are aqueous, especially water and oil emulsions of the W/Oor O/W variety. Water when present will be in amounts which may rangefrom 5 to 95%, preferably from 20 to 70%, optimally between 35 and 60%by weight.

Besides water, relatively volatile solvents may also serve as carrierswithin compositions of the present invention. Most preferred aremonohydric C₁ -C₃ alkanols. These include ethyl alcohol, methyl alcoholand isopropyl alcohol. The amount of monohydric alkanol may range from 1to 70%, preferably from 10 to 50%, optimally between 15 to 40% byweight.

Emollient materials may also serve as pharmaceutically acceptablecarriers. These may be in the form of silicone oils and syntheticesters. Amounts of the emollients may range anywhere from 0.1 to 30%,preferably between 1 and 20% by weight.

Silicone oils may be divided into the volatile and non-volatile variety.The term "volatile" as used herein refers to those materials which havea measurable vapor pressure at ambient temperature. Volatile siliconeoils are preferably chosen from cyclic or linear polydimethylsiloxanescontaining from 3 to 9, preferably from 4 to 5, silicon atoms.

Linear volatile silicone materials generally have viscosities less thanabout 5 centistokes at 25° C. while cyclic materials typically haveviscosities of less than about 10 centistokes.

Nonvolatile silicone oils useful as an emollient material includepolyalkyl siloxanes, polyalkylaryl siloxanes and polyether siloxanecopolymers. The essentially non-volatile polyalkyl siloxanes usefulherein include, for example, polydimethyl siloxanes with viscosities offrom about 5 to about 100,000 centistokes at 25° C. Among the preferrednon-volatile emollients useful in the present compositions are thepolydimethyl siloxanes having viscosities from about 10 to about 400centistokes at 25° C.

Among the ester emollients are:

(1) Alkenyl or alkyl esters of fatty acids having 10 to 20 carbon atoms.Examples thereof include isoarachidyl neopentanoate, isononylisonanonoate, oleyl myristate, oleyl stearate, and oleyl oleate.

(2) Ether-esters such as fatty acid esters of ethoxylated fattyalcohols.

(3) Polyhydric alcohol esters. Ethylene glycol mono and di-fatty acidesters, diethylene glycol mono- and di-fatty acid esters, polyethyleneglycol (200-6000) mono- and di-fatty acid esters, propylene glycol mono-and di-fatty acid esters, polypropylene glycol 2000 monooleate,polypropylene glycol 2000 monostearate, ethoxylated propylene glycolmonostearate, glyceryl mono- and di-fatty acid esters, polyglycerolpoly-fatty esters, ethoxylated glyceryl monostearate, 1,3-butyleneglycol monostearate, 1,3-butylene glycol distearate, polyoxyethylenepolyol fatty acid ester, sorbitan fatty acid esters, and polyoxyethylenesorbitan fatty acid esters are satisfactory polyhydric alcohol esters.

(4) Wax esters such as beeswax, spermaceti, myristyl myristate, stearylstearate and arachidyl behenate.

(5) Sterols esters, of which cholesterol fatty acid esters are examplesthereof.

The most preferred esters are isoarachidyl neopentanoate and isononylisononanoate.

Fatty acids having from 10 to 30 carbon atoms may also be included aspharmaceutically acceptable carriers for compositions of this invention.Illustrative of this category are pelargonic, lauric, myristic,palmitic, stearic, isostearic, hydroxystearic, oleic, linoleic,ricinoleic, arachidic, behenic and erucic acids.

Humectants of the polyhydric alcohol-type may also be employed aspharmaceutically acceptable carriers in compositions of this invention.The humectant aids in increasing the effectiveness of the emollient,reduces scaling, stimulates removal of built-up scale and improves skinfeel. Typical polyhydric alcohols include glycerol, polyalkylene glycolsand more preferably alkylene polyols and their derivatives, includingpropylene glycol, dipropylene glycol, polypropylene glycol, polyethyleneglycol and derivatives thereof, sorbitol, hydroxypropyl sorbitol,hexylene glycol, 1,3-butylene glycol, 1,2,6-hexanetriol, ethoxylatedglycerol, propoxylated glycerol and mixtures thereof. For best resultsthe humectant is preferably propylene glycol. The amount of humectantmay range anywhere from 0.5 to 30%, preferably between 1 and 15% byweight of the composition.

Thickeners may also be utilized as part of the pharmaceuticallyacceptable carrier of compositions according to the present invention.Typical thickeners include crosslinked acrylates (e.g. Carbopol 982®),hydrophobically-modified acrylates (e.g. Carbopol 1382®), cellulosicderivatives and natural gums. Among useful cellulosic derivatives aresodium carboxymethylcellulose, hydroxypropyl methylcellulose,hydroxypropyl cellulose, hydroxyethyl cellulose, ethyl cellulose andhydroxymethyl cellulose. Natural gums suitable for the present inventioninclude guar, xanthan, sclerotium, carrageenan, pectin and combinationsof these gums. Amounts of the thickener may range from 0.0001 to 5%,usually from 0.001 to 1%, optimally from 0.01 to 0.5% by weight.

Collectively the water, solvents, silicones, esters, fatty acids,humectants and/or thickeners will constitute the pharmaceuticallyacceptable carrier in amounts from 1 to 99.9%, preferably from 80 to 99%by weight.

Cosmetic compositions of the present invention may be in any form. Theseforms may include emulsified systems such as lotions and creams,microemulsions, roll-on formulations, mousses, ointments (hydrophilicand hydrophobic), aerosol and non-aerosol sprays and pad-appliedformulations.

Surfactants may also be present in cosmetic compositions of the presentinvention. Total concentration of the surfactant will range from 0.1 to40%, preferably from 1 to 20%, optimally from 1 to 5% by weight of thecomposition. The surfactant may be selected from the group consisting ofanionic, nonionic, cationic and amphoteric actives. Particularlypreferred nonionic surfactants are those with a C₁₀ -C₂₀ fatty alcoholor acid hydrophobe condensed with from 2 to 100 moles of ethylene oxideor propylene oxide per mole of hydrophobe; C₂ -C₁₀ alkyl phenolscondensed with from 2 to 20 moles of alkylene oxide; mono- and di- fattyacid esters of ethylene glycol; fatty acid monoglyceride; sorbitan,mono- and di- C₈ -C₂₀ fatty acids; block copolymers (ethyleneoxide/propylene oxide); and polyoxyethylene sorbitan as well ascombinations thereof. Alkyl polyglycosides and saccharide fatty amides(e.g. methyl gluconamides) are also suitable nonionic surfactants.

Preferred anionic surfactants include soap, alkyl ether sulfate andsulfonates, alkyl sulfates and sulfonates, alkylbenzene sulfonates,alkyl and dialkyl sulfosuccinates, C₈ -C₂₀ acyl isethionates, acylglutamates, C₈ -C₂₀ alkyl ether phosphates and combinations thereof.

Sunscreen actives may also be included in compositions of the presentinvention. Particularly preferred are such materials as ethylhexylp-methoxycinnamate, available as Parsol MCX, and benzophenone-3, alsoknown as Oxybenzone. Inorganic sunscreen actives may be employed such asmicrofine titanium dioxide, polyethylene and various other polymers.Amounts of the sunscreen agents will generally range from 0.1 to 30%,preferably from 2 to 20%, optimally from 4 to 10% by weight.

Preservatives can desirably be incorporated into the cosmeticcompositions of this invention to protect against the growth ofpotentially harmful microorganisms. Suitable traditional preservativesfor compositions of this invention are alkyl esters ofpara-hydroxybenzoic acid. Other preservatives which have more recentlycome into use include hydantoin derivatives, propionate salts, and avariety of quaternary ammonium compounds. Cosmetic chemists are familiarwith appropriate preservatives and routinely choose them to satisfy thepreservative challenge test and to provide product stability.Particularly preferred preservatives are phenoxyethanol, methyl paraben,propyl paraben, imidazolidinyl urea, sodium dehydroacetate and benzylalcohol. The preservatives should be selected having regard for the useof the composition and possible incompatibilities between thepreservatives and other ingredients in the emulsion. Preservatives arepreferably employed in amounts ranging from 0.01% to 2% by weight of thecomposition.

Compositions of the present invention may also contain water-solublevitamins. The term water-soluble defines substances with a solubility ofat least 0.1%, preferably at least 1%, optimally at least 5% by weightin water. Illustrative water-soluble vitamins are Niacin, Vitamin B₆,Vitamin B₆, Vitamin C and Biotin. One source for Vitamin C is a productsold under the trademark of Vitazyme C available from the BrooksCompany. Niacin, Vitamin B and Biotin are available from RochePharmaceuticals. Total amount of vitamins in compositions according tothe present invention may range from 0.001 to 1%, preferably from 0.01to 0.6, optimally from 0.1 to 0.5% by weight.

Keratolytic agents such as C₂ -C₂₅ α-hydroxy alkanoic acids may also beincorporated into compositions of this invention. Illustrative of thisgroup of materials are glycolic, lactic, α-hydroxyoctanoic acids andsalts thereof. The salts may be selected from alkalimetal, ammonium andC₁ -C₂₀ alkyl or alkanolammonium counterions. Levels ofα-hydroxyalkanoic acids may range from 0.001 to 10%, preferably between0.2 and 1%, optimally between 0.4 and 0.5% by weight.

Minor adjunct ingredients may also be present in the cosmeticcompositions. Among them may be the water-insoluble vitamins such asVitamin A Palmitate, Vitamin E Acetate and DL-panthenol.

Another adjunct ingredient can be that of an enzyme. Particularlypreferred is superoxide dismutase, commercially available as Biocell SODfrom the Brooks Company, U.S.A.

Natural vegetable materials from renewable resources are often desirablein cosmetic compositions. For instance, cosmetic compositions of thepresent invention may include β-glucan derived from oats, commerciallyavailable under the trademark Microat SF from Nurture Inc., Missoula,Mont.

Colorants, fragrances, opacifiers and abrasives may also be included incompositions of the present invention. Each of these substances mayrange from about 0.05 to about 5%, preferably between 0.1 and 3% byweight.

The following Examples will more fully illustrate embodiments of thisinvention. All parts, percentages and proportions referred to herein andin the appended claims are by weight unless otherwise indicated.

EXAMPLE 1

The following sunscreen creme was prepared having a compositionindicated under Table 1.

                  TABLE I    ______________________________________    COMPONENT             WEIGHT %    ______________________________________    Carbopol 1382 ® (2% solids)                          8.000    Cyclomethicone        6.000    Parsol MCX ®      6.000    Isoarachidyl Neopentanoate                          4.300    Benzophenone-3        3.000    Glycerin              3.000    Isononyl Isononanoate 2.500    Arlacel 165 VS ® (GMS/PEG)                          1.700    BRIJ 721 ® (Vegetable)                          1.200    Isostearic Acid       1.200    Polymethyl Methacrylate                          1.000    Cetyl Alcohol         1.000    Triethanolamine       0.770    Phenoxyethanol        0.700    Actiglyde-J Special ® (Bio-hyaluronic                          0.500    acid)    Vitamin E Acetate     0.500    BRIJ 72 ® (Vegetable)                          0.300    Methylparaben         0.300    Polyethylene (A-C 400) ®                          0.300    Algae Extract         0.250    Glydant ®         0.200    DL-Panthenol          0.200    C.sub.12 -C.sub.20 Acid-PEG 8 Esters                          0.200    Trilaureth-4-Phosphate                          0.200    Silicone 200 (10 cst) 0.200    Microat SF ®      0.200    Niacin                0.200    Amigel ®          0.170    Vitazyme C ®      0.100    Superoxide Dismutase  0.100    Vitamin B.sub.6       0.100    Vitamin A Palmitate   0.100    Propylparaben         0.100    Disodium EDTA         0.100    L-Lactic Acid         0.010    Biotin                0.001    Deionized Water       qs    ______________________________________

EXAMPLE 2

A creme was prepared having a composition described in Table II.

                  TABLE II    ______________________________________    COMPONENT             WEIGHT %    ______________________________________    Carbopol 1382 ® (2% Solids)                          18.000    Cyclomethicone        6.000    Cetyl Alcohol         4.400    Spectron SA-13 ® (Tridecyl Salicylate)                          4.000    Glycerin              3.000    Isoarachidyl Neopentanoate                          2.400    Emulgade 100 NI ® 1.750    Willowbark Extract    1.500    Triethanolamine 99%   1.420    C.sub.18 -C.sub.36 Fatty Acid                          1.200    BRIJ 721 ® (Vegetable)                          1.200    Arachidyl Behenate    1.000    Actiglyde-J Special ®                          1.000    Polymethyl Methacrylate                          1.000    Vitamin E Acetate     1.000    Sodium Pyrolidone Carboxylate (50%                          0.750    solids)    Algae Extract         0.500    DL-Panthenol          0.500    Silicone 200 (10 cst) 0.400    C.sub.12 -C.sub.20 Acid-PEG 8 Esters                          0.400    Microat SF ®      0.360    Bernel Ester TOC ®                          0.360    Glydant ®         0.300    Methylparaben         0.300    BRIJ 72 ® (Vegetable)                          0.300    Polyethylene (A-C 400) ®                          0.300    Shea Butter           0.200    Disodium EDTA         0.100    Amigel ®          0.100    Propylparaben         0.100    Vitamin A Acetate     0.100    L-Lactic Acid         0.010    Biotin                0.001    Vitazyme C ®      0.001    Deionized Water       qs    ______________________________________

EXAMPLE 3

A clinical study was performed on the compositions of Examples 1 and 2.The objective of this study was to evaluate the dermatologic irritationand acnegenic potential of these two compositions when used underexaggerated conditions for twenty-eight days. The study was a monadictreatment type study. The test panel was comprised of 45 female humanvolunteer subjects (21 using Example 1 and 24 using Example 2). Enrolledsubjects had a facial acne grade of II (Pilsbury) or lower and no facialirritation beyond the specific acne lesions.

On days 1, 8, 15 and 29 the investigator assessed the global facialirritation and acne condition of each subject. The lighting conditions,fluorescent overhead lights in a fluorescent ring lamp with a diopterlens (as needed) were identical for each evaluation. Each subject usedeither product twice daily (morning and evening) for twenty-eight days,recording all use on a diary form.

The investigator's global facial assessments of open lesions, closedlesions, papules, pustules, nodules and irritation were transferred viadata entry from the original data sheets to computer. Analysis wasconducted using the paired sample t-Test on the global mean scoreswithin each product group and on the differences from baseline in globalmean scores for a product vs. product comparison. Significance wasassessed at the p≦0.05 level (95% confidence). Pustules, nodules andirritation scores were negative (0) at all time points. There were nosignificant increases in any acne condition or irritation at any timepoint during the study. At week 1 open lesions for Example 2 decreasedsignificantly (p=0.036). At week 4 open lesions decreased for Example 2and increased for Example 1 indicating a significant difference(p=0.018). At every time point Example 2 demonstrated a decrease in openlesions, closed lesions, and papules. The same conditions worsened at 5of 9 time points for Example 1. When used as directed, neither productwas an irritant.

Although the compositions of Example 1 and 2 vary slightly, the majordifference is the presence of 4% tridecyl salicylate in Example 2. Fromthe above study, it is evident that the tridecyl salicylate had asignificant effect upon treating the conditions of acne while beingnonirritating.

EXAMPLE 4

A microemulsion formulation according to the present invention isoutlined under Table III.

                  TABLE III    ______________________________________    INGREDIENT            WEIGHT (%)    ______________________________________    PPG-5-Ceteth-20       4.00    PEG-40 Hydrogenated Castor Oil                          1.75    Polyglyceryl-10 Decaoleate                          10.50    PEG-8 Caprylic/capric Glycerides                          10.50    SD Alcohol 40         12.00    Isodecyl Neopentanoate                          16.00    Glyceryl Trioctanoate 8.00    DC Silicone Fluid 344 ®                          8.50    Propylparaben         0.15    Isostearic Acid       2.50    Tridecyl Salicylate   3.75    Hydroxycaprilic Acid  0.10    Tocopheryl Acetate    0.25    Phenoxyethanol        0.30    Deionized Water       Q.S    ______________________________________

EXAMPLE 5

A skin lotion (water in oil type) formulation according to the presentinvention is outlined under Table IV.

                  TABLE IV    ______________________________________    INGREDIENT            WEIGHT (%)    ______________________________________    Cetyl Dimethicone     2.50    DC Silicone Fluid 344 ®                          4.00    DC Silicone Fluid 200 ® (20 CST)                          1.25    Squalane              1.75    Octyl Octanoate       2.00    Zinc Myristate        1.25    Dimethicone Copolyol  2.50    Butylene Glycol       4.50    Glycerin              1.50    Sodium Hyaluronate    1.00    Tridecyl Salicylate   6.00    Salacos HS ®      2.50    Isostearic Acid       2.50    Isononyl Isononanoate 3.75    Hydroxycaprilic Acid  0.10    Methylparaben         0.20    Propylparaben         0.10    Tocopheryl Acetate    0.55    Phenoxyethanol        0.20    Deionized Water       Q.S    ______________________________________

EXAMPLE 6

A skin cream (oil in water type) formulation according to the presentinvention is outlined under Table V.

                  TABLE V    ______________________________________    INGREDIENT            WEIGHT (%)    ______________________________________    Hydroxyethylcellulose 0.50    Magnesium Aluminum Silicate                          0.75    Cocoa Butter          1.25    Squalene              1.05    Isostearyl Isononanoate                          2.25    DC Silicone Fluid 200 ® (50 CST)                          1.25    DC Silicone Fluid 200 ® (100 CST)                          0.50    Butylene Glycol       3.00    Glycerin              2.50    Sodium Hyaluronate    0.50    Tridecyl Salicylate   5.00    Glycereth-7 Hydroxystearate                          1.50    Stearic Acid          3.50    Cetyl/Stearyl Alcohol 2.55    Sodium PCA            2.10    Glyceryl Hydroxystearate                          1.25    Tocopherol            0.35    Methylparaben         0.20    Propylparaben         0.10    Glydant ®         0.30    Steareth-20           1.20    Disodium EDTA         0.05    Triethanolamine       1.50    Deionized Water       Q.S    ______________________________________

EXAMPLE 7

An anhydrous serum formulation according to the present invention isoutlined under Table VI.

                  TABLE VI    ______________________________________    INGREDIENT            WEIGHT (%)    ______________________________________    Sepigel 305 ®     1.50    SD Alcohol 40 (200°)                          20.00    DC Silicone Fluid 344 ®                          QS    Squalene              1.05    Octyl Isononanoate    2.25    DC Silicone Fluid 200 ® (10 CST)                          5.25    Isononyl Isononanoate 30.00    Butylene Glycol       1.00    Tocopheryl Linoleate  0.50    Propylparaben         0.10    Tocopheryl Acetate    0.10    Tridecyl Salicylate   2.75    Dimethiconol          2.50    ______________________________________

EXAMPLE 8

A skin lotion (oil in water type) formulation according to the presentinventin is outlined under Table VII.

                  TABLE VII    ______________________________________    INGREDIENT            WEIGHT (%)    ______________________________________    Xanthan Gum           0.20    Magnesium Aluminum Silicate                          0.75    Shea Butter Glycerides                          1.25    Squalene              2.25    Coco Caprylate/Caprate                          3.25    DC Silicone Fluid 200 ® (50 CST)                          0.75    DC Silicone Fluid 200 ® (50 CST)                          0.50    Butylene Glycol       3.00    Glycerin              2.00    Sodium Hyaluronate    0.35    Tridecyl Salicylate   3.50    Cetyl Alcohol         1.00    DEA-Cetyl Phosphate   2.15    Saccharide Isomerate  1.00    Sodium PCA            2.10    Sucrose Laurate       0.50    Ceteth-2              0.50    Methylparaben         0.20    Propylparaben         0.10    Germall II ®      0.30    Steareth-20           1.20    Tocopheryl Acetate    0.20    Disodium EDTA         0.05    Lactic Acid           0.10    Deionized Water       Q.S    ______________________________________

EXAMPLE 9

A protective skin lotion with sunscreen formulation according to thepresent invention is outlined under Table VIII.

                  TABLE VIII    ______________________________________    INGREDIENT            WEIGHT (%)    ______________________________________    Xanthan Gum           0.15    Seppigel 501 ®    1.50    Shea Butter           1.50    Squalene              2.00    Coco Caprylate/Caprate                          2.25    Propylene Glycol      3.55    Dicaprylate/Dicaprate    DC Silicone Fluid 200 ® (20 CST)                          0.50    DC Silicone Fluid 200 ® (350 CST)                          1.00    Butylene Glycol       3.00    Glycerin              1.00    Sodium Hyaluronate    0.35    Tridecyl Salicylate   3.00    Cetyl Alcohol         1.00    DEA-Cetyl Phosphate   1.25    Parsol MCX ®      6.00    Benzophenone-3        3.00    Ceteth-2              0.50    Ceteareth-20          1.20    Methylparaben         0.30    Propylparaben         0.15    Glydant ®         0.20    Aloe Vera Gel         2.00    Tocopheryl Acetate    0.30    Disodium EDTA         0.05    Deionized Water       Q.S    ______________________________________

EXAMPLE 10

A clinical study was performed on the composition of Table IX todetermine performance of tridecyl salicylate as an anti-aging active.

                  TABLE IX    ______________________________________    COMPONENT             WEIGHT %    ______________________________________    Silicone 344 Fluid    15.0    Tridecyl Salicylate   5.0    Silicone 200/100 Fluid                          5.0    Silicone 1401 Fluid   5.0    Actiglide Special ® (Bio-hyaluronic Acid)                          5.0    Squalane              4.0    Butylene Glycol       3.0    Sepigel 305 ®*    3.0    Tween 40 ®        2.5    Germall 115 ®     0.3    Methylparaben         0.2    Disodium EDTA         0.1    Deionized Water       qs    ______________________________________     *Isoparaffin dispersion of a polyacrylamide water solution.

Creepy Skin Measurement

The crepey skin protocol is a clinical visual assessment of forearmskin. This condition is associated with photoaged skin and reflects skinwhich takes on a sagging, rough, wrinkled appearance. The clinical testis 12 weeks in duration and evaluates 2 different test formulations in apaired manner (one on each forearm) using 15 women with moderate forearmcrepiness. The study is conducted in a double blinded manner whereneither the subject or clinical evaluator has knowledge of the testmaterial being applied to the forearms. Only subjects with equivalentcrepiness on both forearms are enrolled.

Assessment

If a formulation is effective it is anticipated that an improvement inforearm crepiness would be observed from baseline. To compare therelative performance of the 2 test formulations, the better formulawould show greater/faster improvement in forearm crepiness as comparedto the companion formulation. The following "directed-difference" scaleis utilized to measure to what extent one formulation is superior to thecompanion formulation.

0=no difference

1=slightly better

2=moderately better

3=much better

4=dramatically better

A directed-difference scale is used to quantitate any perceiveddifference between right and left treated forearms. If there is noperceivable difference between forearms a 0 is noted. In the event oneforearm is better, the more improved forearm is given a score from 1 to4 (smallest to greatest) where these values represent a difference levelof improvement over the companion treated forearm. The forearm which isshowing greater improvement will therefore attain a higher averageabsolute score. One treatment is arbitrarily given a negative assignmentwhile the other is given the positive assignment. In these experiments,the tridecyl salicylate formulations were given a negative assignmentwhereas the vehicle was given a positive assignment.

Results of the clinical are provided in Table X. They show that thetridecyl salicylate formulation is superior to the vehicle. This isevident as the directed difference scores are in the negative directionfavoring the tridecyl salicylate formulation. The only differencebetween the vehicle and experimental formulations is tridecylsalicylate. All other ingredients, pH, etc. are the same.

                  TABLE X    ______________________________________    Clinical Anti-Aging Performance    5% Tridecyl Salicylate vs. Vehicle                       MEAN IMPROVEMENT    Week               OVER VEHICLE    ______________________________________    0                  0    4                  +0.12    8                  +1.0*    12                 +0.6    ______________________________________     *Significantly better than vehicletreated group.

The foregoing description and examples illustrate selected embodimentsof the present invention. In light thereof, various modifications willbe suggested to one skilled in the art, all of which are within thespirit and purview of this invention.

What is claimed is:
 1. A method for treatment of acne and pimplesconsisting essentially of applying to the skin a safe and effectiveamount of a salicylate ester in a pharmaceutically acceptable carrier,the salicylate ester having the formula (I): ##STR3## wherein R is a C₁₁-C₃₀ alkyl or alkenyl radical.
 2. The method according to claim 1wherein the salicylate ester is tridecyl salicylate.